atorvastatin in factorial with omega-3 fatty acid risk reduction in diabetes …in an academic...
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Atorvastatin in Factorial with Omega-3 fatty acid Risk Reduction in Diabetes
…in an academic collaboration with
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Trial DesignTrial Design Collaborative academic and pharmaceutical study
Funded by Pfizer, with data owned, analysed and reported by the University of Oxford Diabetes Trials Unit (DTU)
Multi-centre primary prevention trial in 1,000 patients with type 2 diabetes
Double-blind, placebo-controlled
2 x 2 factorial randomisation to• Atorvastatin (Lipitor 20 mg/day)• Omega 3 PUFA (Omacor 2g/day)
70 UK clinical centres, one year follow-up
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Steering CommitteeOverall responsibility for scientific, professional
and operational conduct of the study
Diabetes Trials UnitStudy Design and Protocol Dev.Co-ordinating CentreInvestigator agreementsEthical/regulatory approvalData collection and managementProtocol/clinical queriesStatistical analysis/publication
Pfizer UKProtocol development Regulatory aspectsStudy medication On-site MonitoringSAE reporting
DTU CentralLaboratory
70 Clinical Centres
Trial Organisation
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AimsAimsTo determine the:
Range of estimated CHD risk levels typically seen in people with type 2 diabetes in UK general practice
Proportion whose estimated ten-year CHD risk can be reduced below 15% with a 20 mg of atorvastatin or 1.8 g omega-3 PUFA/day
Degree to which atorvastatin and omega-3 PUFA in combination have additive effects
Extent to which therapy adherence can be enhanced using a simple behavioural intervention
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Inclusion CriteriaInclusion Criteria Aged 18 years and above
Have had type 2 diabetes for at least 3 months
Not known to have had a cardiovascular event
Have provided written informed consent
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Exclusion CriteriaExclusion Criteria Taking prescribed lipid lowering therapy
Triglycerides ≥8.0 mmol/L
Have specific contraindications toatorvastatin or omega-3 PUFA
Have participated in a clinical trialwithin the last 3 months
Are pregnant or lactating females
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Atorvastatin Placebo 500Omega-3 Omega-3 Omega-3
(250) (250)
Atorvastatin Placebo 500
Placebo Placebo Placebo(250) (250)
500 500 1,000Atorvastatin Placebo patients
in total
Atorvastatin (20 mg )
Omega-3PUFA (1.8 g)
2 x 2 Factorial Randomisation2 x 2 Factorial Randomisation
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Primary ObjectivesPrimary Objectives
Proportion of subjects whose LDL levels are<2.6 mmol/L at four months
Proportion of subjects whose triglycerides are<1.5 mmol/L at four months
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Secondary ObjectivesSecondary Objectives Proportion of subjects with LDL levels
<2.6 mmol/L at one year
Proportion of subjects with triglycerides<1.5 mmol/L at one year
Proportion (%) of subjects with estimated ten-year CHD risk <15% at 16 weeks and one year
Study medication adherenceat 16 weeks and at one year
Health economic assessmentat 16 weeks and at one year
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Visit ScheduleVisit ScheduleVisit 1: week -2 Recruitment
Visit 2: week 0 Randomisation
Visit 3: week 16 Four month evaluation
Visit 4: week 18 Additional medication*Adherence study
Visit 5: week 32 Routine Follow up
Visit 6: week 52 One year evaluationEnd of study
* Patients whose estimated CHD risk remains greater than 20% at four months will receive an additional tablet containing 20 mg atorvastatin, whilst the remainder will receive an additional placebo tablet, in double-blind fashion.
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Study will commence in 2004
One year recruitment in 70 UK practices
One year follow-up for all subjects
Results expected 2006
Contact:
• Email: [email protected]
• Phone: 01865 857 246
• Fax: 01865 857 256
• Web site:www.dtu.ox.ac.uk/aforrd
Trial ScheduleTrial Schedule